Changing Lifestyle in Children (ALLChange)

January 7, 2016 updated by: University of Dundee

Changing Lifestyle in Children: All Change: Can This Reduce Cardiovascular Risk?

A lifestyle intervention aimed at improving exercise levels in primary school children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Children 9-11 yrs

Exclusion Criteria:

  • Children <9 yrs and >12 yrs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Behavioral: Eating habits, diet and exercise
Programme of change to eating habits, diet and exercise
Experimental: Active 2
Active
Behavioral: Eating habits, diet and exercise
Programme of change to eating habits, diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Can an acceptable strategy, based on social cultural factors that influence adherence to the strategy and designed for altering lifestyle associated with CV risk (ALL CHANGE) be developed for school aged children?

Secondary Outcome Measures

Outcome Measure
Is ALL CHANGE more effective in altering lifestyle than conventional health education delivered as part of the school curriculum?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

University of St Andrews

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

October 30, 2009

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2003CV40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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